DURHAM – Grid Therapeutics has received clearance from the U.S. Food and Drug Administration to begin human testing of its new cancer immunotherapy.

The Duke University biotech spin-off – based in Durham – announced that the FDA has approved its investigational new drug (IND) application for GT103 to treat solid tumors. The approval means Grid can begin a Phase 1 clinical trial to investigate the therapy to treat patients with refractory – or recurring – non-small cell lung cancer.

Grid said it expects to begin the trial in the next two months at Duke University Health System. The company plans to add more sites later.

“The FDA’s IND clearance for GT103 marks a critical milestone for Grid Therapeutics as we evaluate this first-in-class therapeutic in the clinic,” said Edward F. “Ned” Patz Jr., M.D., the company’s CEO. “We believe GT103 has the potential to improve clinical responses in lung cancer patients, including those who are refractory to currently approved immunotherapies.”

Grid was established in 2016, based on Patz’s research at Duke. A clinical radiologist there, he has led a laboratory focused on lung cancer biology and early cancer detection.

Grid licensed the exclusive global rights to GT103 from Duke to develop the first human-derived antibody as a targeted immunotherapy for cancer. The therapy is based on an antibody that inhibits Complement Factor H (CFH), a protein that protects cancer cells. The company is using its immunotherapy platform to develop a pipeline of human-derived, tumor-targeted antibodies to treat a variety of cancers.

(C) N.C. Biotech Center